Hydrocortisone

Manufacturer: Twenty-First Century Healthcare Fund, L.L.C. | Westwood Laboratories Inc.
Effective date: 2020-04-28
Label type: OTC ANIMAL DRUG LABEL
Version: 11
Source: legacy-cache
Hydrated at: 2026-08-01 23:33:08

Label at a glance#

ProductHydrocortisone

Active ingredientHYDROCORTISONE ACETATE

Label structure8 sections

Indications and uses

to soothe: • itching • flea bites • dermatitis • skin irritations • eczema

Dosage and administration

• rinse pet with warm water until coat is thoroughly wet • massage shampoo thoroughly into the coat • continue massaging and add water during the process to make sure the shampoo is thoroughly distributed through the coat • leave the pet in lather for 5-10 minutes keeping the pet warm and out of drafts • rinse thoroughly and dry • for best results use at least twice a week or as directed by a veterinarian • Indivi...

Contacts and useful links#

PhoneLabel contact(800) 530-2178

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate 0.50%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses:

INDICATIONS & USAGE SECTION

to soothe: • itching • flea bites • dermatitis • skin irritations • eczema

Warnings

WARNINGS SECTION

For external use only. Use for all adult dogs.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

and animals to avoid unintended consumption.

Do not use:

OTC - DO NOT USE SECTION

• in eyes or nose •where infection (pus) is present, since the drug may allow infection to be spread •on pregnant animals.

• if product appears to be tampered with. Not for prolonged use.

Stop use and ask veterinarian

OTC - STOP USE SECTION

if redness, irritation, or swelling persists or increases.

Directions

DOSAGE & ADMINISTRATION SECTION

• rinse pet with warm water until coat is thoroughly wet

• massage shampoo thoroughly into the coat

• continue massaging and add water during the process to make sure the shampoo is thoroughly distributed through the coat

• leave the pet in lather for 5-10 minutes keeping the pet warm and out of drafts

• rinse thoroughly and dry

• for best results use at least twice a week or as directed by a veterinarian

• Individual result may vary

Other information

SPL UNCLASSIFIED SECTION

Store product in cool. dry place. Avoid temperatures above 86F.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Sodium Lauryl Ether Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine. Cocamidopropylamine Oxide, PEG-3 Distearate,

Aloe Barbadensis Leal Juice, Lauryl Glucoside, Triethanolamine. Lactic Acid, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance.

Questions

OTC - QUESTIONS SECTION

(800) 530-2178

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROCORTISONE ACETATE	ACTIVE INGREDIENT	3X7931PO74	4
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	4
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	4
COCAMIDOPROPYLAMINE OXIDE	INACTIVE INGREDIENT	M4SL82J7HK	4
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	4
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	4
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	4
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER	INACTIVE INGREDIENT	39DK5WQ2PR	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
PEG-3 DISTEARATE	INACTIVE INGREDIENT	8420ECX438	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SODIUM LAURETH-2 SULFATE	INACTIVE INGREDIENT	ZZQ59TY3KG	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	4
Water	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

Hydrocortisone
HYDROCORTISONE ACETATE
Water
SODIUM LAURETH-2 SULFATE
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER
COCAMIDOPROPYL BETAINE
COCAMIDOPROPYLAMINE OXIDE
PEG-3 DISTEARATE
ALOE VERA LEAF
LAURYL GLUCOSIDE
TROLAMINE
LACTIC ACID
DMDM HYDANTOIN
METHYLPARABEN
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60754-920	60754-920-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROCORTISONE ACETATE	3X7931PO74	ACTIB
Water	059QF0KO0R	IACT
SODIUM LAURETH-2 SULFATE	ZZQ59TY3KG	IACT
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER	39DK5WQ2PR	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
COCAMIDOPROPYLAMINE OXIDE	M4SL82J7HK	IACT
PEG-3 DISTEARATE	8420ECX438	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
LAURYL GLUCOSIDE	76LN7P7UCU	IACT
TROLAMINE	9O3K93S3TK	IACT
LACTIC ACID	33X04XA5AT	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 194 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION, SOLUTION / INTRAVENOUS		87 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SUSPENSION / TOPICAL	0.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	GEL / TOPICAL		30 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	AEROSOL, FOAM / TOPICAL		11 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	American Health Packaging	506aab0d-9308-4d60-90b3-7d64952fff36	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Preferred Pharmaceuticals, Inc.	247bb729-f0b6-4325-a9f8-4b46d5cda300	2026-08-28	Adverse reactions	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	5f87d7fb-f258-48b0-8b60-1055e22ebd71	2026-08-25	Warnings	Name fallback brand name: Hydrocortisone
Claravie	HYDROCORTISONE ACETATE	Gentell LLC	598d224b-d12e-89bf-e063-6394a90a84dc	2026-08-21	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone	HYDROCORTISONE	Safetec of America, Inc.	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	2026-08-13	Warnings	Name fallback brand name: Hydrocortisone
HYDROCORTISONE	HYDROCORTISONE	Amazon.com Services LLC	f40b4223-e81f-4cd0-bc9b-d3d33ce8cce5	2026-08-12	Warnings	Name fallback brand name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Solco Healthcare LLC	04f112e5-ec88-46c8-b675-8b4e38a86ab4	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Name fallback brand name: hydrocortisone
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Name fallback generic name: HYDROCORTISONE ACETATE
Hydrocortisone	HYDROCORTISONE	REMEDYREPACK INC.	f0e66726-946b-4f63-b457-2851dc69e6b4	2026-08-03	Adverse reactions	Name fallback brand name: Hydrocortisone
hydrocortisone	HYDROCORTISONE	Eywa Pharma Inc	b3f06d10-2f01-428c-88a4-505c61c87ce8	2026-07-25	Warnings, Adverse reactions	Name fallback brand name: hydrocortisone
Hydrocortisone	HYDROCORTISONE	AKRON PHARMA INC	daad9a1e-98d2-4ce7-9d97-ac5d81905abb	2026-07-22	Warnings	Name fallback brand name: Hydrocortisone
Hydrocortisone	HYDROCORTISONE LOTION	Allegis Holdings LLC	1a27d8fa-4025-ed68-e063-6394a90a4f37	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone
Hydrocortisone	HYDROCORTISONE	Encube Ethicals, Inc.	11e120e2-a1ca-477c-b474-bcbb72656705	2026-06-26	Adverse reactions	Name fallback brand name: Hydrocortisone
Hydrocortisone	HYDROCORTISONE	Mylan Pharmaceuticals Inc.	bc751403-94f2-4f9d-b533-cf6186a40ceb	2026-05-25	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	04758c46-0ca4-4852-acdc-1f8553ce2e6e	2026-05-21	Adverse reactions	Name fallback brand name: Hydrocortisone
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	02ab1006-c7c8-42c9-bda8-62c9d7142521	2026-05-11	Adverse reactions	Name fallback brand name: Hydrocortisone
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	058bb2ff-ff51-4a3b-ba47-cb02272d0631	2026-05-11	Adverse reactions	Name fallback brand name: Hydrocortisone
hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	12cd35e3-e707-4551-b778-bf615c1a8d32	2026-05-11	Warnings	Name fallback brand name: hydrocortisone
HYDROCORTISONE	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	0bbb8a63-ae1d-41d7-b201-d1b171b31f46	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.